Evaluation of the IFuse Bedrock Technique in Association with Posterior Lumbosacral Fusion with Iliac Fixation.

NCT05276024 | Recruiting

• 1 other identifier: 2021-ORT03
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to describe the impact of the iFuse Bedrock technique to decrease post-operative pains in patients who underwent multilevel posterior lumbosacral fusion.

Conditions

Sacroiliitis; Sacroiliac; Fusion; Lumbosacral; Fusion; Spine Deformity

Keywords

Sacroiliac joint pain; Sacroiliac joint fusion; Bedrock technique; Open posterior lumbosacral fusion; Spine deformties

Outcome Measures

Primary Outcomes (1)

• Change from baseline in self-reported Oswestry Disability Index (ODI) at 12 months

  A decrease of 16 points in the ODI score at 12 months compared to the preoperative score is expected in order to demonstrate a 30% effecacy of the iFuse Bedrock technique in reducing postoperative pain.

  12 months

Secondary Outcomes (14)

• Change from baseline in sacroiliac joint pain provocation tests.

  During 12 months

• Assessment of the Oswestry Disability Index

  3 and 6 months

• Improvement of back and leg pains at 3, 6 and 12 months compared to preoperative scores

  3, 6 and 12 months

• Change in Patient's quality of life

  3, 6 and 12 months

• Proportion of subjects with postoperative SIJ fusion failure

  12 months

Study Arms (1)

iFuse Bedrock technique

Multilevel lumbar fusion procedure with additional sacroiliac joint stabilization using the iFuse-3D system

Device: iFuse Bedrock technique

Interventions

iFuse Bedrock technique DEVICE

Lumbosacral arthrodesis on 2 or more spinal segments (including at least L4, L5 and S1 vertebrae) associated with a sacroiliac fusion procedure according to the Bedrock technique using the iFuse 3D system and iliac fixation.

iFuse Bedrock technique

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All participants enrolled in the study are adult subjects who underwent an open posterior lumbosacral fusion procedure with additional sacroiliac joint fusion according to the iFuse Bedrock technique (insertion of the iFUSE-3D implant). Lumbosacral fusion involved at least the following vertebrae : L4, L5 and S1.

You may qualify if:

• Subject scheduled for open posterior lumbosacral arthrodesis (including at least the following three vertebrae: L4, L5 and S1) associated with a sacroiliac fusion procedure and iliac fixation (thoracolumbar fusion procedures extended to sacrum are eligible in the study);
• Insertion of at least 1 iFuse-3D implant according to the iFuse Bedrock technique (uni- and bilateral insertion are eligible);
• Subject who preoperatively responded positively to pain provocation tests for SIJ dysfunction with or without a positive SIJ infiltration test;
• Patient with a degenerative sacroiliac joint disease requested a fusion procedure;

You may not qualify if:

• Major osteoporosis (DEXA scan \> 3);
• Any previous history of sacroiliac joint fusion or any surgical procedure involving a S2-iliac fusion;
• Subjects requested a SIJ fusion without the iFuse-3D device or iFuse-3D not inserted according to the manufacturer instruction (Bedrock technique);
• Subjects with a medical or surgical contraindication preventing the intervention from being performed or potentially interfering in the interpretation of the data collected (neurologic condition, local or systemic infection, any known allergy to surgical implants, psychiatric diseases, ...);
• Currently pregnant or planning pregnancy;
• Prisoner or a ward of the state;
• Subject no willing to participate in the study;
• Subject not affiliated to a social security insurance.

Sponsors & Collaborators

• Polyclinique Bordeaux Nord Aquitaine: lead
• SI-BONE, Inc.: collaborator

Study Sites (2)

Polyclinique Bordeaux Nord Aquitaine

Bordeaux, 33300, France

RECRUITING

Hôpitaux Universitaires de Marseille

Marseille, 13005, France

RECRUITING

MeSH Terms

Conditions

Sacroiliitis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases

Study Officials

• Jean Charles Le Huec, M.D., PhD

  VERTEBRA Institute, Polyclinique Bordeaux Nord Aquitaine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stéphane Bourret

CONTACT

+33(0)556437017; s.bourret@bordeauxnord.com

Lisa Boue

CONTACT

+33(0)556437017; l.boue@bordeauxnord.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2022
• First Posted: March 11, 2022
• Study Start: June 10, 2022
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: November 8, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)